Deals and Financings

Taimei Technology, a Shanghai-Jiaxing SAAS company, completed a $212 million Series E/E+ round to advance its cloud AI-based suite of clinical trial programs (see story). The company says its platform enables clinical research collaboration between sponsors, sites, CROs, patients, regulatory agencies and third-party providers. Founded in 2013, Taimei already offers six technology-enabled programs: data management, project management, electronic regulatory submission, central medical imaging, pharmacovigilance and drug logistics. It plans to expand into other areas of life science R&D.

Ansun Biopharma of San Diego closed an $80 million Series B funding from China investors to advance its innovative antiviral (see story). The company's lead product is a first-in-class recombinant sialidase protein that removes sialic acid from the surface of airway epithelial cells, preventing the virus from entering the host. In the US, the FDA has granted the candidate Fast Track Eligibility and Breakthrough Therapy to treat lower respiratory tract infections caused by parainfluenza virus (PIV) in immunodeficient patients. It is also thought to be effective against resistant flu strains.

dMed Biopharma, a Shanghai CRO that offers clinical trial services in China, the US and the EU, completed a Series B financing of nearly $50 million, led by Vivo Capital and joined by Legend Capital, Qiming Venture Partners and Lilly Asia Ventures (see story). Launched three years ago, dMed considers itself a "next-gen" clinical CRO with efficient operations, IT services and expertise in cross-border global trials. The company has 600 employees. Recently, dMed acquired Target Health, a full service New York-based CRO, to expand its global offerings and add new technologies.

Shaanxi Micot Technology raised $16 million in a Pre-A financing to develop its portfolio of novel multi-targeted polypeptide drug candidates (see story). Founded in 2007, Micot is located in Xi'an. The company says its bispecific polypeptides are activated simultaneously through separate signals to maximize bioactivity and minimize side effects. It is developing 16 candidates in cardiovascular, pain, calcium/phosphorus metabolism and diabetes indications. The round was led by Northern Light Venture Capital, with participation from Tasly Capital, Detong Capital and Shanxi Investment.

CanSino Biologics (HK: 6185), a Tianjin vaccine company, filed to IPO on the Shanghai Star Board, six months after it completed a $161 million initial offering in Hong Kong (see story). In the first day of trading following the Hong Kong IPO, CanSino rose 58%, and it remains 72% above the IPO price six months later. The company said it would issue 24.8 million shares in the Shanghai offering, but it has not set its pricing goals yet. CanSino has an approved Ebola vaccine and six vaccine candidates in clinical trials or CTA stage, along with 6 pre-clinical vaccine candidates.

Guangzhou Boji Medical Biotech (SHE: 300404), a CRO, formed a JV with Great Bay Bio of Hong Kong to develop GBB101, a novel long-acting injectable biologic designed to treat anemia caused by chronic kidney disease (see story). Great Bay is an AI-based CMC CDMO focused on innovative biologics. The two companies, which expect GBB101 to be one of the first long-acting anti-anemia products from a China biopharma, will each invest capital in the JV, though details were not provided.

Chengdu HitGen formed a partnership with Galapagos NV (GLPG) using HitGen's drug discovery platform to identify small molecule leads for targets specified by Galapagos (see story). HitGen, which has formed partnerships with over 60 pharmaceutical companies, says its DNA-encoded library contains 400 billion novel, diverse, drug-like small molecule and macrocyclic compounds. In July, HitGen announced it would stage a $97 million IPO on Shanghai's STAR market. Galapagos is a clinical-stage Belgo-Dutch pharma that was founded in 1999.

Trials and Approvals

Japan's Eisai (TSE: 4523) was approved for a China launch of its antiepileptic (AED) drug Fycompa® as an adjunct treatment of partial onset seizures in epilepsy patients at least 12 years old (see story). A first-in-class oral AED, Eisai describes Fycompa as a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation by targeting glutamate activity at AMPA receptors on postsynaptic membranes. The drug was discovered at Eisai's Tsukuba Research Laboratories. China's NMPA reviewed Eisai's NDA filing for Fycompa under Priority Review rules.

Shanghai's I-Mab Biopharma has been approved to conduct China Phase II/III trials of an anti-CD38 antibody in patients with multiple myeloma (see story). The company in-licensed China rights to MOR202/TJ202 two years ago from Germany's MorphoSys (FSE: MOR) in a $120 million agreement. The Phase II/III trials are an extension of MorphoSys' Phase II/III global trials as well as I-Mab's similar trials in Taiwan. I-Mab owns rights for MOR202/TJ202 in China, Taiwan, Hong Kong and Macao.

Luqa Pharma, a Shanghai specialty in-licensing pharma, together with Adare Pharma of France, announced that Lactéol®, a microbiome treatment for diarrhea, was approved for China use (see story). Lactéol ® is a proprietary combination of Lactobacillus LB (Lactobacillus fermentum and Lactobacillus delbrueckii) and neutralized fermented culture medium. An oral prescription drug, it will be available in sachets in China hospitals. Founded in 2010, Luqa has built a portfolio of products for wound healing, acne, scar treatments, fungal infections, gastrointestinal and aesthetic products, which it markets in greater China.